Treatment and relapse of interstitial lung disease in nivolumab-treated patients with non–small cell lung cancer

Masafumi Sata, Shinichi Sasaki, Katsunori Oikado, Yoshinobu Saito, Junya Tominaga, Fumikazu Sakai, Terufumi Kato, Tae Iwasawa, Hirotsugu Kenmotsu, Masahiko Kusumoto, Tomohisa Baba, Masahiro Endo, Yutaka Fujiwara, Hiroaki Sugiura, Noriyo Yanagawa, Yoshihiko Ito, Takahiko Sakamoto, Yuichiro Ohe, Kazuyoshi Kuwano

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)


Nivolumab, a human monoclonal antibody against programmed death-1, is approved for the treatment of non–small cell lung cancer (NSCLC). Although nivolumab is generally well tolerated, it can cause interstitial lung disease (ILD), a rare but potentially fatal immune-related adverse event. Currently, there are limited data available on the treatment of nivolumab-induced ILD and its outcome. This retrospective cohort study based on a post–marketing study described the treatment of nivolumab-induced ILD and its outcome in NSCLC patients in Japan through the assessment of clinical and chest imaging findings by an expert central review committee. Treatment details for patients who experienced a relapse of ILD were also analyzed. Of the 238 patients identified as having nivolumab-induced ILD, 37 patients died of ILD. Corticosteroids were used in 207 (87.0%) patients. Of those, 172 (83.1%) patients responded well and survived and 35 (16.9%) died (most died during corticosteroid treatment). A total of nine patients experienced a relapse; at the time of relapse, four patients were taking nivolumab. Of those who were receiving corticosteroids at the time of relapse, three of four patients were taking low doses or had nearly completed dose tapering. All patients (except one, whose treatment was unknown) received corticosteroids for the treatment of relapse, but one patient died. Patients with NSCLC who experience nivolumab-induced ILD are treated effectively with corticosteroids, and providing extra care when ceasing or reducing the corticosteroid dose may prevent relapse of ILD.

Original languageEnglish
Pages (from-to)1506-1513
Number of pages8
JournalCancer science
Issue number4
Publication statusPublished - 2021 Apr


  • Adverse drug events
  • Immunotherapy
  • Interstitial lung disease
  • Nivolumab
  • Non-small-cell lung carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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